不同取栓装置在急性缺血性卒中治疗中的有效性与安全性：1项回顾性比较研究

doi:10.3969/j.issn.1673-5765.2026.04.009

摘要/Abstract

摘要： 目的比较国产Captor®取栓装置与进口SolitaireTM取栓装置在急性缺血性卒中（acute ischemic stroke，AIS）机械取栓治疗中的有效性与安全性。
方法本研究为单中心回顾性研究，连续纳入2024年3月—2025年11月在秦皇岛市第一医院接受机械取栓治疗的AIS患者，根据实际使用器械分为Captor®组和SolitaireTM组。主要有效性终点为首轮血管再通[改良脑梗死溶栓（modified thrombolysis in cerebral infarction，mTICI）分级2b/3级]及最终血管再通；次要有效性终点包括取栓次数、术后24 h及出院时NIHSS评分、NIHSS评分改善程度（入院评分-出院评分）、90 d良好预后（mRS评分0～2分）和手术时间。安全性终点包括术后24 h出血事件、围手术期血管并发症、90 d全因死亡及90 d卒中复发。
结果本研究共纳入181例AIS患者，其中Captor®组159例，SolitaireTM组22例。两组基线人口学特征及主要临床资料均衡，但Captor®组高血压患病比例低于SolitaireTM组（P=0.047）。首轮血管再通率[99.4%（157/158）vs. 100%（18/18），P=0.998]及最终血管再通率[98.1%（156/159）vs. 95.5%（21/22），P=0.407]差异均无统计学意义。Captor®组取栓次数显著少于SolitaireTM组[（1.03±0.24）次 vs.（1.23±0.61）次，P=0.004]。两组间术后24 h NIHSS评分［11.0（6.5～16.0）分 vs. 11.0（9.0～18.5）分，P=0.510］、出院时NIHSS评分［6.0（3.0～17.0）分 vs. 6.5（4.0～15.2）分，P=0.930］、NIHSS评分改善程度［4.0（-0.2～9.0）分 vs. 6.5（0.5～15.0）分，P=0.213］、90 d良好预后率[30.6%（37/121）vs. 47.4%（9/19），P=0.129]和手术时间［90（72～110）min vs. 105（53～115）min，P=0.678］的差异均无统计学意义。Captor®组术后24 h出血事件发生率为0.8%（1/132），SolitaireTM组为0（0/19），差异无统计学意义（P=0.349）；两组均未发生围手术期血管并发症（P=0.957）。两组90 d全因死亡率[26.4%（32/121）vs. 21.1%（4/19），P=0.277]差异无统计学意义。两组均未观察到90 d卒中复发事件（P=0.277）。
结论国产Captor®取栓装置在AIS治疗中具有良好的有效性和安全性，其临床表现可能与进口SolitaireTM取栓装置相当，但仍需前瞻性随机临床试验进一步验证。

文章导读： 国产Captor®取栓装置与进口SolitaireTM取栓装置在AIS治疗中的有效性和安全性相当，仍需前瞻性研究进一步验证。

关键词: 急性缺血性卒中; 机械取栓; Captor?; SolitaireTM; 血管再通; 安全性

Abstract: Objective To compare the efficacy and safety of the domestic Captor® thrombectomy device with the imported SolitaireTM thrombectomy device in mechanical thrombectomy for acute ischemic stroke (AIS).
Methods This was a single-center retrospective study that consecutively enrolled patients with AIS who underwent mechanical thrombectomy at the First Hospital of Qinhuangdao between March 2024 and November 2025. Patients were classified into the Captor® or SolitaireTM group according to the thrombectomy device used. The primary efficacy endpoints were the first-pass recanalization [modified thrombolysis in cerebral infarction (mTICI) grade 2b/3] and the final recanalization. Secondary efficacy endpoints included the number of thrombectomy passes, NIHSS scores at 24 hours post-procedure and at discharge, the degree of NIHSS improvement (admission score minus the discharge score), 90-day favorable prognosis (mRS score 0-2), and procedure time. Safety outcomes included 24-hour postoperative hemorrhagic events, perioperative vascular complications, 90-day all-cause mortality, and 90-day stroke recurrence.
Results A total of 181 patients with AIS were enrolled in this study, including 159 in the Captor® group and 22 in the SolitaireTM group. Baseline demographic characteristics and major clinical data were comparable between the two groups, except for the prevalence of hypertension, which was significantly lower in the Captor® group (P=0.047). No significant differences were observed in the first-pass recanalization rate [99.4% (157/158) vs. 100% (18/18), P=0.998] or the final successful recanalization rate [98.1% (156/159) vs. 95.5% (21/22), P=0.407]. The Captor® group required fewer thrombectomy passes than the SolitaireTM group [(1.03±0.24) times vs. (1.23±0.61) times, P=0.004]. There were no statistically significant differences between the two groups regarding the 24-hour postoperative NIHSS score [11.0 (6.5-16.0) vs. 11.0 (9.0-18.5), P=0.510], NIHSS score at discharge [6.0 (3.0-17.0) vs. 6.5 (4.0-15.2), P=0.930], the degree of NIHSS improvement [4.0 (-0.2-9.0) vs. 6.5 (0.5-15.0), P=0.213], 90-day favorable prognosis rate [30.6% (37/121) vs. 47.4% (9/19), P=0.129], or procedure time [90 (72-110) minutes vs. 105 (53-115) minutes, P=0.678]. The incidence of 24-hour postoperative hemorrhagic events was 0.8% (1/132) in the Captor® group and 0 (0/19) in the SolitaireTM group, with no significant difference between the two groups (P=0.349). No perioperative vascular complications occurred in either group (P=0.957). Likewise, 90-day all-cause mortality [26.4% (32/121) vs. 21.1% (4/19), P=0.277] was similar between the groups. No 90-day stroke recurrence events were observed in either group (P=0.277).
Conclusions The domestic Captor® thrombectomy device demonstrates favorable efficacy and safety that may be comparable to the SolitaireTM thrombectomy device in the treatment of AIS. Further prospective randomized clinical trials are needed to confirm these findings.

Key words: Acute ischemic stroke; Mechanical thrombectomy; Captor?; SolitaireTM; Recanalization; Safety

中图分类号:

刘元昊, 吴磊, 杨欢, 朱佳颖, 李亚哲. 不同取栓装置在急性缺血性卒中治疗中的有效性与安全性：1项回顾性比较研究[J]. 中国卒中杂志, 2026, 21(4): 463-470.

LIU Yuanhao, WU Lei, YANG Huan, ZHU Jiaying, LI Yazhe. Efficacy and Safety of Different Thrombectomy Devices in the Treatment of Acute Ischemic Stroke: A Retrospective Comparative Study[J]. Chinese Journal of Stroke, 2026, 21(4): 463-470.

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链接本文: https://www.chinastroke.org.cn/CN/10.3969/j.issn.1673-5765.2026.04.009

https://www.chinastroke.org.cn/CN/Y2026/V21/I4/463

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